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»IRB Submission & Approval Process

+-IRB Protocol Submission Process

Research projects that include the participation of human subjects are required to submit to the IRB for approval. This process is summarized in the Submission Procedure Flowchart (PDF).

The first step in submitting an IRB protocol application is to determine whether your research falls under one of three OHRP Categories: Exempt, Expedited, or Full Committee Review. Definitions of each category can be found below. If you are unsure of which category your research falls into, contact the IRB for clarification before completing any of the application forms. The Committee may elect to move your research into another category following review of the protocol.

Once you have completed the appropriate application form and obtained the required signatures, submit the application via email toirb@chapman.edu with any supplemental materials* for review (and revision if necessary).

Please do not submit scanned or copied applications. All applications must be submitted in their original form to the irb@chapman.edu mailbox. Signature pages only may be submitted separately as may be required to obtain all signatures.

Do not submit multiple applications in a single email. Please send individual applications separately.

Once received electronically by the IRB, the review time will vary based on the type of application submitted (see below). For Full Committee Review, a schedule of meetings for this fiscal year is provided.

IRB REVIEWSubmission Deadline Schedule

FULL REVIEW

Submission Deadline

IRB Meeting Date

July 15, 2014

August 11, 2014*

August 15, 2014

September 8, 2014

September 15, 2014

October 13, 2014

October 15, 2014

November 10, 2014

November 17, 2014

December 8, 2014

December 15, 2014

January 12, 2015 (TBD)

January 15, 2015

February 9, 2015

February 16, 2015

March 9, 2015

March 16, 2015

April 13, 2015

April 15, 2015

May 11, 2015

May 15, 2015

June 8, 2015

June 15, 2015

July 13, 2015 (TBD)

EXPEDITED REVIEW

Within 3-4 weeks of submission, process should be completed.

EXEMPT REVIEW(Includes Course-Related)

Within 2-3 weeks of submission, process should be completed.

*SIGNED COVER SHEETS SHOULD BE SCANNED IN BLACK & WHITE AT 300dpi

+-IRB Protocol Review Process

Protocols that are categorized as exempt are reviewed by the IRB Administrator and the IRB Faculty Chair. Expedited protocols are reviewed by the IRB Administrator, IRB Faculty Chair and one or two members of the Boards as needed, depending on the study details.

Protocols that are categorized for Full Review will be assigned two members of the IRB Committee as "primary reviewers". One or both of them will contact you prior to the monthly Full Committee Review meeting to request any additional information, supplemental materials, or to discuss initial concerns. The full IRB Committee will then review the protocol, render a decision, and will notify the Principal Investigator. The protocol will either be Approved, Approved with Modifications, Tabled for Discussion to an ad-hoc or full committee, or Not Approved.

If the protocol is Approved: the principal investigator will receive a letter of approval and the necessary documents to proceed with the research.

If the protocol is Approved with Modifications: the primary reviewers will send the requested modifications back to the Principal Investigator for revision. Once the revisions have been made and satisfy the committee, the investigator will receive a letter of approval and the necessary documents to proceed with the research.

If the protocol is Tabled for Discussion pending additional information or revisions: the IRB will return the protocol and outline the major concerns for the investigator. The protocol will be placed on the agenda of the next Full Committee Meeting as long as revisions are received in a timely manner. The IRB may also decide to convene an ad-hoc committee to review and approved the requested revisions if time is of the essence.

If the protocol is Not Approved: the IRB will notify the investigator, the Human Subjects Protection Officer (Y. Uzzell) and the Institutional Official (D. Struppa) on its decision. It is the IRB's policy to work with the investigator to make the necessary revisions needed to approve the protocol.